Closely-held Lutronic Vision’s R:GEN laser has treated its first central serous chorioretinopathy (CSC) patient at Seoul National University Hospital (SNUH).
In CSC, the retinal pigment epithelium (RPE) leaks, causing fluid to accumulate in the subretinal space, which can cause visual impairment and retinal detachment. R:GEN transfers energy to the retina to repair the leaks in the RPE.
R:GEN is available to treat CSC patients following the Ministry of Health and Welfare’s July 2018 approval of the R:GEN’s conditional new health technology assessment (nHTA). The approval designated SNUH as a participating medical institution and allows for out-of-pocket medical treatment and collection of clinical data.
“The conditional approval is mutually beneficial: patients are able to access treatment for CSC with R:GEN, while Lutronic collects data from treated patients to support the device’s [final] approval,” Jhung Vojir, Lutronic’s president and COO, said in a statement.
R:GEN has received Korea’s Ministry of Food and Drug Safety approval for CSC and diabetic macular edema (DME); U.S. FDA approval for clinically significant macular edema; and CE Mark for the treatment of CSC, DME and the dry form of age-related macular degeneration (AMD).
“We are looking forward to working with SNUH as it treats CSC patients, while we continue to prepare to initiate clinical trials of R:GEN in another ophthalmic indication later this year,” she added.
Lutronic is also developing R:GEN for the treatment of early-stage AMD, and plans to initiate clinical trials in Australia by the end of 2019.